Manufacturing Engineer

Confidential • Saint Paul, Minnesota • Posted June 10, 2026
About the Role

Job Description:
We are seeking a Manufacturing Engineer with at least 2 years of experience in a regulated manufacturing environment, preferably within the medical device industry, to support and enhance manufacturing operations with a strong focus on process validation planning and execution. This role is ideal for an engineer who already has hands-on validation experience and wants to deepen their expertise in medical device process validation while contributing to process development, improvement, and manufacturing scale-up.
Responsibilities:
Support and execute process validation activities in compliance with FDA regulations and internal quality requirements.
Participate in validation planning by assisting with strategy development, risk assessments, protocol drafting, and planning reviews.
Support and execute validation activities, including IQ/OQ/PQ, data collection, data analysis, and preparation of validation reports.


        
    